FDA approves first marijuana-based drug for seizures

[Kalitaur]

https://www.cbsnews.com/news/fda-approves-epidiolex-first-marijuana-based-drug-for-seizures/

U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

 

[VivaRevolution]

https://www.cbsnews.com/news/fda-approves-epidiolex-first-marijuana-based-drug-for-seizures/

U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

That's kind of a big deal that the FDA cleared a drug based on weed.

 

[Madmick]

https://www.cbsnews.com/news/fda-approves-epidiolex-first-marijuana-based-drug-for-seizures/

U.S. health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. CBD is one of more than 100 chemicals found in marijuana. But it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.

The FDA approval for Epidiolex is technically limited to patients with Dravet and Lennox-Gastaut syndromes, two rare forms of epilepsy for which there are few treatments. But doctors will have the option to prescribe it for other uses.

Great first step, but it's all meaningless until it's removed from Schedule I.

Researchers just can't get their hands on it while it has that classification.

 

[Midnighter]

Great first step, but it's all meaningless until it's removed from Schedule I.

Researchers just can't get their hands on it while it has that classification.

What do you mean?

 

[HomeRun916]

Seems like a reasonable starting point.

 

[Fuzzybabyducks]

good first federal step... glad more states are making it legal also.. I dont smoke but it brings in money.

 

[Madmick]

What do you mean?

Cliffs: higher education consists of various types of schools: technical schools, seminaries, institutes of technology, and so on, but chiefly colleges and universities. Universities are just a collection of many different types of colleges under one umbrella, and they typically also include institutions for postgraduate study. Not all universities have the same focus or development. The highest level for a university is to be classified as a "Research 1" or "R1" which conveys that the university has a more evolved postgraduate infrastructure, and that there is a focus beyond merely teaching students, but also pushing the envelope of human knowledge with research. They derive prestige from this platform.

There are only 115 Research 1 universities in the USA:
https://en.wikipedia.org/wiki/List_of_research_universities_in_the_United_States#Universities_classified_as_"R1:_Doctoral_Universities_–_Highest_Research_Activity"

"Schedule I" refers to the most strict classification for a substance according to our DEA's drug scheduling under the Controlled Substances Act:
https://www.dea.gov/druginfo/ds.shtml

True or False? “Schedule I” Drugs Aren’t Eligible for Research

Schedule I drugs are “the most dangerous class of drugs” and have “no currently accepted medical use and a high potential for abuse.” They include heroin, LSD, marijuana and ecstasy. In contrast, the DEA classifies cocaine, methamphetamine, OxyContin and Adderall as Schedule II drugs. Xanax, Valium and Ambien fall under Schedule IV.

Multiple news sources have reported on the difficulty of conducting research on marijuana because it’s classified as a Schedule I drug. We also addressed this difficulty when Chuck Rosenberg, acting head of the DEA, falsely said smoking marijuana has “never been shown to be safe or effective as a medicine” back in November.

Donald Abrams, a marijuana researcher at the University of California, San Francisco, told us by phone that one hurdle researchers must overcome is obtaining a license from the DEA to study Schedule I drugs. In order to obtain a license, the DEA has to examine a researcher’s facility to make sure it’s safe to store Schedule I substances, he said. The Food and Drug Administration also notes this on its website.

Another hurdle is obtaining the marijuana for study from the National Institute on Drug Abuse. As the FDA explains, the NIDA has “contracts with the University of Mississippi to grow marijuana for use in research studies.” This is the “only legal source” of marijuana for research in the U.S., says Abrams. The Los Angeles Times also reported on this issue in May 2014.

“The problem is that the NIDA … has a congressional mandate that they can only study substances of abuse as substances of abuse. So if you want to study cannabis for potential medical benefit you have to be funded by someone else,” Abrams told us. So obtaining marijuana for study is less of an impediment than obtaining funding for the research, he said.

According to an analysis by News21, a student journalism project at Arizona State University, the National Institutes of Health granted $1.1 billion in funding for research on marijuana abuse and addiction between 2008 and 2014. Comparatively, the NIH spent $297 million on research concerning marijuana’s potential medical benefits and effects on the brain.

Still, it’s not impossible to study marijuana’s harms or benefits as a drug, as Clinton claimed.

Abrams, for example, is currently funded by the National Heart, Blood and Lung Institute to conduct research on the medical benefits of marijuana on sickle cell anemia patients. He also pointed us to the Center for Medicinal Cannabis Research, which coordinates “rigorous scientific studies to assess the safety and efficacy of cannabis and cannabis compounds for treating medical conditions.”

When we emailed Clinton’s office asking for support for her claim, a campaign representative made many of the points we have above. The representative also accurately noted, “All [marijuana] studies have to undergo review through the FDA’s Investigational New Drug process for drug development,” in addition to the hurdles outlined above.

Clinton’s representative pointed us to an April 2016 Scientific American article, in which Sachin Patel, an associate professor of psychiatry at Vanderbilt University, says, “Rescheduling cannabis as Schedule II will allow the research to get done that needs to be done to determine if this is going to be a good medicine, and for what.”

https://www.vox.com/2014/9/25/6842187/drug-schedule-list-marijuana

To many people, one of the more bewildering aspects of the scheduling system is that marijuana is schedule 1 — the same category as heroin — while cocaine and meth are schedule 2.

But that doesn't necessarily mean the federal government views marijuana and heroin as equally dangerous drugs, or that it considers marijuana to be more dangerous than meth or cocaine. Schedule 1 and 2 drugs are both described as having "a high potential for abuse" — a vague description that doesn't rank drugs in the two categories as equal or different.

The big distinction between schedule 1 and 2 substances, instead, is whether the federal government thinks a drug has medical value. The DEA says schedule 2 substances have some medical value and schedule 1 substances do not, so the latter receive more regulatory scrutiny even though they may not be more dangerous.

The war on drugs was initiated when much of the nation was in hysterics about what drugs would do to the moral fabric of the country

It may be helpful to think of the scheduling system as made up of two distinct groups: nonmedical and medical. The nonmedical group comprises the schedule 1 drugs, which are considered to have no medical value and high potential for abuse. The medical group comprises the schedule 2 to 5 drugs, which have some medical value and are numerically ranked based on abuse potential.

It's not impossible, but Clinton wasn't misleading anyone. He was speaking to the practical truth. This funnels everything through the FDA, and sets up so many regulatory roadblocks that it makes it practically impossible for these universities to just get their hands on the damn drug so they can study it.

The highlighted above just shows how absurd and anachronistic our drug laws are. They aren't keeping up. It's infuriating how incompetent our lawmakers have been to react to these problems in a timely, effective manner. I don't have a problem with drugs like cocaine assigned to Schedule II. Meanwhile, I do take issue with heroin being Schedule I while morphine isn't, and I really take issue with marijuana remaining Schedule I.

It's a goddamn joke, and the joke is on us-- the people.